FDA Regulatory News
Refine Search
Biotechnology
The US Food and Drug Administration (FDA) has granted another approval for Dupixent (dupilumab), for the treatment of adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU) who remain symptomatic despite histamine-1 (H1) antihistamine treatment. 19 April 2025
Pharmaceutical
In keeping with US Department of Health and Human Services Secretary Robert F Kennedy Jr’s promise to carry out the Department’s work with “radical transparency” and mitigate perceived industry influence and conflicts of interests, Food and Drug Administration (FDA) Commissioner Dr Martin Makary, has announced a policy directive. 19 April 2025
Biotechnology
Dutch gene therapy company uniQure (Nasdaq: QURE) announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to AMT-130, sending the firm’s shares leaping more than 38% to $13.00 by close of trading on Thursday. 18 April 2025
Biotechnology
The US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for Eylea HD (aflibercept) Injection 8mg, submitted by US biotech Regeneron Pharmaceuticals. 18 April 2025
Pharmaceutical
India’s Venus Remedies has secured Qualified Infectious Disease Product designation from the United States Food and Drug Administration for its investigational antibiotic VRP-034, a next-generation formulation of polymyxin B designed to reduce kidney toxicity. 17 April 2025
Pharmaceutical
Italian pharma major Recordati today announced that the US Food and Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Isturisa (osilodrostat) for the treatment of endogenous hypercortisolemia in adults with Cushing’s syndrome for whom surgery is not an option or has not been curative. 16 April 2025
Biosimilars
The US Food and Drug Administration (FDA) has designated Yuflyma (adalimumab-aaty) as an interchangeable biosimilar to AbbVie’s mega blockbuster drug Humira (adalimumab), to treat eight conditions, including Crohn's disease and ulcerative colitis. 15 April 2025
Pharmaceutical
US gastrointestinal (GI) and rare diseases specialist Ironwood Pharmaceuticals was trading 34% lower early Monday. 14 April 2025
Pharmaceutical
Deal-making news last week included US drug developer KalVista Pharma signing a licensing agreement with Kaken Pharma to market its investigational hereditary angioedema (HAE) drug sebetralstat in Japan. US biotech firm Cartesian Therapeutics released positive Phase IIb data on its Descartes-08 in myasthenia gravis. The US Appeal Court gave a favorable ruling on Indian drugmaker Sun pharmaceuticals’ alopecia drug Leqselvi. Also of note, the US Food and Drug Administration (FDA) last week approved Bristol Meyers Squibb’s checkpoint therapy Opdivo plus Yervoy. 13 April 2025
Biotechnology
Late Thursday, the US Food and Drug Administration revealed it is taking a ground-breaking step to advance public health by replacing animal testing in the development of monoclonal antibody (MAb) therapies and other drugs with more effective, human-relevant methods. 11 April 2025
Pharmaceutical
Swiss biopharma Idorsia has received approval from the US Food and Drug Administration for an updated label on its hypertension drug Tryvio (aprocitentan), removing the previous Risk Evaluation and Mitigation Strategy requirement. 9 April 2025
Biosimilars
Israel-based Teva Pharmaceuticals industries today revealed two important updates reflecting its commitment to expanding access to both biosimilars and innovative medicines. 7 April 2025
Biotechnology
The US Food and Drug Administration (FDA) has approved Uplizna (inebilizumab-cdon) as the first and only treatment for adults living with immunoglobulin G4-related disease (IgG4-RD), the drug’s developer, Amgen announced yesterday. 4 April 2025
Pharmaceutical
US biotech Aldeyra Therapeutics has received a Complete Response Letter from the US Food and Drug Administration (FDA) for the resubmission of the New Drug Application (NDA) of its dry eye disease candidate reproxalap. 4 April 2025
Biotechnology
US biotech Novavax is still waiting on a decision from the Food and Drug Administration over full approval of its protein-based COVID-19 vaccine, despite the agency having set an April 1 target date to complete its review. 4 April 2025
Pharmaceutical
Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. 3 April 2025
Pharmaceutical
Freed from their former obligations to remain loyal to agency and state, a number of high-profile figures from the US Food and Drug Administration (FDA) have sounded the alarm about its direction of travel under Robert Francis Kennedy Jr (RFK Jr), the new Secretary of Health and Human Services. 2 April 2025
Biotechnology
AstraZeneca’s Imfinzi (durvalumab) in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by Imfinzi as adjuvant monotherapy after radical cystectomy (surgery to remove the bladder) has been approved in the USA for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). 31 March 2025
Pharmaceutical
Novartis announced late Friday that the US Food and Drug Administration (FDA) approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor pathway inhibitor (ARPI) therapy and are considered appropriate to delay chemotherapy. 31 March 2025
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Qfitlia (fitusiran), the first antithrombin-lowering (AT) therapy for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients (aged 12 or older) with hemophilia A or B with or without factor VIII or IX inhibitors. 31 March 2025
Biotechnology
The US Food and Drug Administration (FDA) on Friday approved nivolumab and hyaluronidase-nvhy, under the trade name Opdivo Qvantig, from US pharma major Bristol Myers Squibb, for subcutaneous injection. 28 December 2024
Biotechnology
The US Food and Drug Administration (FDA) has approved Tevimbra (tislelizumab-jsgr), in combination with platinum and fluoropyrimidine-based chemotherapy, for the first-line treatment of unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma (G/GEJ) in adults whose tumors express PD-L1 (≥1), Sino-China biotech BeiGene. 27 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has issued the Federal Register notice, Modifications to Labeling of Buprenorphine-Containing Transmucosal Products for the Treatment of Opioid Dependence, to encourage the submission of supplemental new drug applications to modify the labeling statements for buprenorphine-containing transmucosal products for the treatment of opioid dependence (BTODs). 27 December 2024
Generics
The US Food and Drug Administration (FDA) revealed on Monday that it has approved the first generic referencing Victoza (liraglutide injection) 18 milligram/3 milliliter. 24 December 2024
Pharmaceutical
US pharma major Eli Lilly today announced the US Food and Drug Administration (FDA) approved Zepbound its (tirzepatide) as the first and only prescription medicine for adults with moderate-to-severe obstructive sleep apnea (OSA) and obesity. 23 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) on Friday approved an expanded indication for Imcivree (setmelanotide), from Boston, USA-based Rhythm Pharmaceuticals, to include children as young as two years old. 23 December 2024
Pharmaceutical
US pharma giant Pfizer on Friday revealed that the US Food and Drug Administration (FDA) has approved its Braftovi (encorafenib) in combination with cetuximab and mFOLFOX6 (fluorouracil, leucovorin, and oxaliplatin) for the treatment of patients with metastatic colorectal cancer (mCRC) with a BRAF V600E mutation, as detected by an FDA-approved test. 23 December 2024
Biotechnology
Denmark’s Novo Nordisk said late Friday that the US Food and Drug Administration (FDA) has approved Alhemo (concizumab-mtci) injection. 22 December 2024
Pharmaceutical
Denmark’s Zealand Pharma has been hit with a complete response letter (CRL) from the US regulator for glepaglutide, a long-acting GLP-2 analog. 20 December 2024
Pharmaceutical
The US Food and Drug Administration (FDA) has approved Tryngolza (olezarsen) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome (FCS), a rare, genetic form of severe hypertriglyceridemia (sHTG) that can lead to potentially life-threatening acute pancreatitis (AP). 20 December 2024
Pharmaceutical
Privately-held Xcovery Holdings, an oncology-focused pharma company, has announced that the US Food and Drug Administration (FDA) has approved Ensacove (ensartinib) for the treatment of patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). 19 December 2024
Biotechnology
December 19, 2024
The US Food and Drug Administration (FDA) approved Ryoncil (remestemcel-L-rknd), from Australia’s Mesoblast, whose shares rocketed 54% to A$3.05 on the news. 19 December 2024
Biotechnology
Safi Biotherapeutics, a specialist in stem-cell derived red blood cell products, has received Rare Pediatric Disease designation and Orphan Drug designation from the US regulator. 19 December 2024
Biosimilars
The US Food and Drug Administration (FDA) has approved Steqeyma (ustekinumab-stba), a biosimilar to Johnson & Johnson’s Stelara, from South Korea’s Celltrion. 18 December 2024
Biotechnology
The US Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed on or after platinum-based chemotherapy, said Gilead Sciences. 17 December 2024
Biotechnology
The US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for clesrovimab (MK-1654), Merck & Co’s prophylactic long-acting monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season. 17 December 2024
Pharmaceutical
Neurocrine Biosciences has secured US Food and Drug Administration approval for Crenessity (crinecerfont). 17 December 2024
Biotechnology
The US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) for a fixed combination of Rybrevant (amivantamab) and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) in non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) mutations. 17 December 2024
Biotechnology
Switzerland’s Galderma has won US Food and Drug Administration (FDA) approval for the use of Nemluvio (nemolizumab) for patients aged 12 years and older with moderate-to-severe atopic dermatitis (AD), alongside topical corticosteroids (TCS) and/or calcineurin inhibitors (TCI), when the disease is not adequately controlled with topical prescription therapies. 16 December 2024
Sign up to receive email updates
Join industry leaders for a daily roundup of biotech & pharma news
Today's issue
Company Spotlight
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze